Augmented suture construct for syndesmotic stabilization

ABSTRACT

A method includes forming a bone tunnel through a first bone and a second bone and inserting a flexible construct through the bone tunnel. The flexible construct includes a first anchoring element and a second anchoring element coupled by at least one flexible strand defining an adjustable loop. The at least one flexible strand includes a first end extending from the first anchoring element in an opposite direction from the adjustable loop. A length of the adjustable loop is adjusted to position the first bone and the second bone in a selected spacing. The first end of the at least one flexible strand is coupled to a tissue section using a third anchoring element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Provisional Application Ser. No. 62/553,410, filed on Sep. 1, 2017, entitled “AUGMENTED SUTURE CONSTRUCT FOR SYNDESMOTIC STABILIZATION,” which is incorporated by reference herein in its entirety.

BACKGROUND

Various injuries include separation of soft tissue from one or more bones and/or separation of bones from normally anatomical correct positioning. Maintaining the bones in the correct anatomical positions during healing is important to provide proper soft tissue reattachment and proper bone healing. For example, during syndesmosis repair, current systems maintain a first bone and a second bone in a fixed position to allow the connective tissue to refuse.

Fixation of a first bone and a second bone can allow some connective tissue to refuse, but not all. Connective tissue that is partially and/or completely separated from the first bone and/or the second bone may not reconnect and/or may reconnect in an undesirable and/or loose location. Failure to properly position tissue during a syndesmosis procedure can lead to additional surgeries or failure of the syndesmotic correction.

SUMMARY

In various embodiments, a method is disclosed. The method includes a step of forming a bone tunnel through a first bone and a second bone. A flexible construct is inserted through the bone tunnel. The flexible construct includes a first anchoring element and a second anchoring element coupled by at least one flexible strand defining an adjustable loop. The at least one flexible strand including a first end extending from the first anchoring element in an opposite direction from the adjustable loop. A length of the adjustable loop is adjusted to position the first bone and the second bone in a selected spacing. The first end of the at least one flexible strand is coupled to a tissue section using a third anchoring element.

In various embodiments, an anchoring system is disclosed. The anchoring system includes an anchoring construct and a tissue anchor. The anchoring construct includes a first anchor, a second anchor, and a first flexible strand defining an adjustable loop extending between the first anchor and the second anchor. The first flexible strand has a first end extending away from the first and second anchors. The tissue anchor is coupled the first end of the flexible strand and is configured to couple the first end of the flexible strand to a first tissue section.

In various embodiments, a system is disclosed. The system includes a bone plate having a body extending between a bone facing surface and an opposing surface. The body defines a hole sized and configured to receive a portion of a flexible construct therethrough. The system further includes a flexible strand coupled to the bone plate at a first end and a tissue anchor coupled to a second end of the flexible strand. The tissue anchor is configured to couple the flexible strand to a tissue section.

BRIEF DESCRIPTION OF DRAWINGS

The features and advantages of the present invention will be more fully disclosed in, or rendered obvious by the following detailed description of the preferred embodiments, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:

FIG. 1 illustrates an anchoring construct coupled to a first bone and a second bone, in accordance with some embodiments.

FIG. 2 illustrates a front view of the anchoring construct of FIG. 1, in accordance with some embodiments.

FIG. 3 illustrates a cross-section taken along line A-A in FIG. 1, in accordance with some embodiments.

FIG. 4 illustrates a tissue anchor having a flexible strand looped through a channel, in accordance with some embodiments.

FIG. 5 illustrates a tissue anchor having a flexible strand passed through a channel, in accordance with some embodiments.

FIG. 6 illustrates a tissue anchor having an eyelet with a flexible strand extending therethrough, in accordance with some embodiments.

FIG. 7 illustrates an anchoring construct having a flexible construct coupled thereto, in accordance with some embodiments.

FIG. 8 illustrates an anchoring construct including a knot capsule, in accordance with some embodiments.

FIG. 9 illustrates a method of syndesmosis, in accordance with some embodiments.

FIG. 10 illustrates an anchoring construct including an anchor having an internal peg, in accordance with some embodiments.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top,” “bottom,” “proximal,” “distal,” “superior,” “inferior,” “medial,” and “lateral” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. As used herein, proximal/distal refers to a relationship between an identified element (such as a surgical instrument) and a user (e.g., a surgeon) grasping or manipulating the identified element.

In various embodiments, an anchoring construct for syndesmotic repair is disclosed. The anchoring construct includes a bone plate coupled to a first bone. The bone plate defines a first hole extending therethrough. A flexible strand is coupled to the bone plate. The flexible strand can be looped through the first hole and/or anchored to the bone plate by an anchoring element (such as a knot capsule, a button, a screw, and/or any other suitable anchoring element). The flexible strand extends from the bone plate to a tissue anchor. The tissue anchor is configured to be coupled to a tissue section remote from the first bone, such as a second bone, a spaced apart section of the first bone, and/or soft-tissue. A length of an intermediate portion of the flexible strand extending from the bone plate to the tissue anchor is adjustable to maintain a selected spacing between the first bone and the remote tissue section. The anchoring construct maintains the first bone and the second bone in a constrained position allowing a predetermined amount of motion (such as 0-5 mm) while maintaining the first and second bone in a suitable position for soft tissue reattachment and repair.

In various embodiments, a system for syndesmotic repair is disclosed. The system includes a flexible construct having at least one adjustable loop defined by a first flexible strand. The adjustable loop is configured to extend through a bone tunnel defined in a first bone and a second bone. A first anchor is positioned at a first end of the adjustable loop and is configured to anchor the adjustable loop to the first bone. The first anchor can include a knot capsule, a bone plate, a flat button, screw and/or any other suitable anchoring element. The second end of the adjustable loop is coupled to the second bone by a second anchoring element. The second anchoring element can include a knot capsule, a flat button, a screw, and/or any other suitable anchoring element. The adjustable loop can be shortened to maintain the first bone and the second bone at a select spacing. A second flexible strand extends from the first anchoring element and is coupled to a tissue anchor. The tissue anchor is configured couple the second flexible strand to a tissue section remote from the first anchoring element, such as the first bone, the second bone, and/or a soft tissue section. An intermediate portion of the second flexible strand is adjustable and is configured to maintain a selected spacing between the first anchor and the remote tissue section. The tissue anchor can be configured to further anchor the second flexible strand to one of the first bone or the second bone.

FIGS. 1-3 illustrate a surgical site 2 including a first bone 4 and a second bone 6 coupled by an anchoring construct 10, in accordance with some embodiments. The anchoring construct 10 is configured to maintain the first bone 4 and the second bone 6 at a selected spacing. As a non-limiting example, in some embodiments, the first bone 4 is a fibula and the second bone 6 is a tibia. The anchoring system 10 includes a bone plate 12 configured to be coupled the first bone 4. The bone plate 12 includes a body 14 extending between a bone contacting surface 16 a and an opposed surface 16 b. The body 14 is further defined by a sidewall 18 defining a perimeter of the bone plate 12 and extending between the bone contacting surface 16 a and the opposed surface 16 b. In some embodiments, the body 14 defines one or more fastener holes 20 a, 20 b extending from the opposed surface 16 b to the bone contacting surface 16 a. The fastener holes 20 a, 20 b are sized and configured to receive a fastener therein to couple the bone plate 12 to the first bone 4. For example, in various embodiments, the fastener holes 20 a, 20 b are sized and configured to receive a fastener, such as a screw, peg, pin, a knot capsule, and/or any other suitable fastener therein.

In some embodiments, at least one flexible strand 22 a extends from the bone plate 12. In the illustrated embodiments, a first flexible strand 22 a and a second flexible strand 22 b extend from the bone plate 12. The flexible strands 22 a, 22 b can include any suitable material, such as sutures, ribbons, tape, threads, rope, and/or any other suitable material. A first end 26 a of each of the flexible strands 22 a, 22 b extends through and/or is coupled to the bone plate 12. The flexible strands 22 a, 22 b each extend from the first end 26 a to a second end 26 b. The second end 26 b is configured to be coupled to a tissue section that is remote from (e.g., spaced apart from) the bone plate 12.

In some embodiments, the first end 26 a of a flexible strand 22 b is passed around and therethrough the body 14 of the bone plate 12 to define a loop 76. For example, as illustrated in FIG. 3, the first end 26 a of the second flexible strand 22 b is passed through a first opening 24 a formed in the bone plate 12 and coupled to an intermediate portion 26 c of the second flexible strand 22 b to define the loop 76. In some embodiments, the first end 26 a is coupled to the intermediate portion 26 c of the flexible strand 22 b by a knot 80. The knot 80 can be any suitable knot, such as, for example, a slip-knot, a fixed knot, and/or any other suitable knot. In some embodiments, one or more of the flexible strands 22 a, 22 b are coupled to the bone plate 12 by an interference fit. For example, as illustrated in FIG. 3, the first end 26 a of the first flexible strand 22 a is positioned between a bone-facing surface 16 a of the bone plate 12 and an outer surface of the first bone 4. The first end 26 a of the first flexible strand 22 a is maintained in a fixed position by an interference fit between a bone plate 12 and an outer surface of the first bone 4. Although specific embodiments are discussed herein, it will be appreciated that the flexible strands 22 a, 22 b can be coupled to the bone plate 12 using any suitable coupling mechanism, such as posts, knots, fastener, and/or any other suitable mechanism.

In some embodiments, the second end 26 b of each of the flexible strands 22 a, 22 b configured to be coupled to a tissue section remote from the bone plate 12. For example, as best seen in FIG. 2, in some embodiments, the second end 26 b of each of the flexible strands 22 a, 22 b is coupled to the second bone 6. The second end 26 b of each of the flexible strands 22 a, 22 b is coupled to the second bone 6 by respective tissue anchors 40 a, 40 b. The tissue anchors 40 a, 40 b are inserted into respective anchor holes 74 a, 74 b formed in the second bone 6. The anchors 40 a, 40 b can be inserted through any suitable method, such as impaction, rotation, and/or any other suitable insertion method. Various embodiments of anchors are illustrated in FIGS. 4-6 and discussed in greater detail below. In other embodiments, the tissue anchors 40 a, 40 b are additionally and/or alternatively configured to couple the flexible strands 22 a, 22 b to soft tissue, such as connective tissue, ligaments, muscle, etc.

In some embodiments, an intermediate portion 26 c of each of the flexible strands 22 a, 22 b extending between the bone plate 12 and the respective anchors 40 a, 40 b has an adjustable length. The bone plate 12 is coupled to the first bone 4 and the second end 26 b of each of the flexible strands 22 a, 22 b is coupled to the second bone 6. The length of the intermediate portion 26 c of the respective flexible strands 22 a, 22 b is adjusted to maintain the first bone 4 and the second bone 6 in a selected spacing. For example, in some embodiments, the flexible strands 22 a, 22 b each define an adjustable loop extending between the bone plate 12 and a respective tissue anchor 40 a, 40 b. In other embodiments, the flexible strands 22 a, 22 b are advanced through a hole 24 a, 24 b formed in the bone plate 12 and/or a channel 44 in the respective anchor 40 a, 40 b to decrease a length of an intermediate portion 26 c of the flexible strand 22 a, 22 b extending between the bone plate 12 and the respective tissue anchor 40 a, 40 b. The intermediate portion 26 c of each of the one or more flexible strands 22 a, 22 b is adjusted to maintain the first bone 4 and the second bone 6 in a selected position, such as a substantially anatomically correct position and/or to position soft tissue adjacent to one of the first bone 4 and/or the second bone 6.

In some embodiment, the first flexible strand 22 a is maintained at a selected length by an interference fit between the second bone 6 and a body 42 a of the first tissue anchor 40 a. Similarly, the second flexible strand 22 b is maintained at a selected length by an interference fit between the second bone 6 and a body 42 b of the second tissue anchor 40 b. The flexible strands 22 a, 22 b are positioned between respective anchors 40 a, 40 b and an inner surface 72 of a respective anchor hole 74 a, 74 b formed in the second bone 6. When the anchors 40 a, 40 b are driven into respective anchor holes 74 a, 74 b, the flexible strands 22 a, 22 b are captured between the outer surface 52 of the body 42 a and the second bone 6. Although embodiments are discussed herein having an interference fixation of the flexible strands 22 a, 22 b, it will be appreciated that the flexible strands 22 a, 22 b can be fixed at a selected length using any suitable fixation mechanism, such as an interference fit, a knot, a post, and/or any other suitable fixation between the tissue anchors 40 a, 40 b and the respective flexible strand 22 a, 22 b.

The anchoring construct 10 is configured to facilitate soft tissue repair between the first bone 4 and the second bone 6 (i.e., syndesmosis). After an injury, soft tissue can be partially and/or completely disconnected from the first bone 4 and/or the second bone 6. In order to facilitate soft tissue repair, the bone plate 12 is coupled to the first bone using one or more fasteners inserted through fastener holes 20 a, 20 b defined through the bone plate 12. For example, in some embodiments, one or more screws, pegs, and/or other fasteners are inserted through at least one of the fastener holes 20 a, 20 b to couple the bone plate 12 to the first bone 4. After coupling the bone plate 12 to the first bone 4, the second end 26 of each of the flexible strands 22 a, 22 b is coupled to the second bone 6. The flexible strands 22 a, 22 b can be coupled to the second bone 6 by inserting tissue anchors 40 a, 40 b into respective anchor holes 74 a, 74 b formed in the second bone 6. The anchor holes 74 a, 74 b can be formed prior to and/or simultaneous with insertion of the tissue anchors 40 a, 40 b. Prior to and/or simultaneous with insertion of the tissue anchors 40 a, 40 b, an intermediate portion 26 c of each of the flexible strands 22 a, 22 b can be adjusted to position and/or maintain the first bone 4 at a selected spacing with respect to the second bone 6. In some embodiments, the selected spacing facilitates repair and/or reattachment of soft tissue with respect to the first bone 4 and/or the second bone 6.

In some embodiments, the flexible strands 22 a, 22 b are configured to attach soft tissue to one of the first bone 4 and/or the second bone 6. Prior to insertion of the tissue anchors 40 a, 40 b into the second bone 6, one or more of the flexible strands 22 a, 22 b can be passed through and/or otherwise coupled to soft tissue. For example, in various embodiments, one or more of the flexible strands 22 a, 22 b can be coupled to a ligament, a muscle, connective tissue, and/or other soft tissue. The flexible strands 22 a, 22 b can be coupled to the soft tissue by a tissue anchor 40 a, 40 b, by passing the flexible strands 22 a, 22 b through the soft tissue (for example, with a needle), and/or any other suitable method. In some embodiments, the tissue anchors 40 a, 40 b are coupled to one of the first bone 4 and/or the second bone 6 to couple the soft tissue to the selected bone 4, 6. The soft tissue can be coupled to the selected bone 4, 6 at a substantially anatomically correct position, although it will be appreciated that soft tissue can be coupled to any suitable position of the selected bone 4, 6 to facilitate repair and/or reattachment of soft tissue.

FIGS. 4-6 illustrate various tissue anchors 40 c-40 d configured to couple a second end 26 b of a respective flexible strand 22 a, 22 b to a tissue section, such as the second bone 6, in accordance with some embodiments. As illustrated in FIG. 4, in some embodiments, a tissue anchor 40 c includes a body 42 c defining a channel 44 extending from a first end 46 a to a second end 46 b. The channel 44 is sized and configured to receive a flexible strand 22 c therethrough. The channel 44 can be concentric with the body 42 c and/or can be offset with respect to a center of the body 42 c. The outer surface 52 of the body 42 c can include one or more fixation features 54 configured to couple the tissue anchor 40 c to a tissue section. The fixation features 54 can include any suitable features, such as threads, ribs, fins, and/or any other suitable fixation feature.

In some embodiments, a second end 26 b of a flexible strand 22 c is passed through the passage 44 to form a loop 48 about a portion of the body 42 c. The flexible strand 22 c is passed into the channel 44 from the first end 46 a (and around an upper edge 50 a) to the second end 46 b. The flexible strand 22 c is further passed around a bottom edge 50 b of the body 42 a. The flexible strand 22 c is returned to a first end 46 a of the body 42 c along an outer surface 52 of the body 42 c to form loop 48. In other embodiments, as shown in FIG. 5, the flexible strand 22 c is passed from the first end 46 a along an outer surface 52 of the body 42 c, passed under the bottom edge 50 b, and returned to the first end 46 a through the channel 44. In this embodiments, no loop is formed in the flexible strand 22 c.

As discussed above with respect to FIGS. 1-3, the flexible strand 22 c interacts with (e.g., is positioned adjacent to and/or coupled to) a bone plate 12 and/or other anchor at a first end 22 a. A length of the intermediate portion 26 c of the flexible strand 22 c extending between the bone plate 12 and the respective anchor 40 c is adjustable by pulling the second end 26 b of the flexible strand 22 c. As the second end 26 b is pulled, the flexible strand 22 c advances through the channel 44 and the length of the intermediate portion 26 c is reduced, resulting in a corresponding adjustment of the position of the first bone 4 with respect to the second bone 6.

In some embodiments, the upper edge 50 a and/or the lower edge 50 b of the body 42 c are rounded, curved, or smooth to prevent damage to and/or cutting of the flexible strand 22 c. For example, in some embodiments, the upper edge 50 a is positioned near a first end 46 a and defines a first opening of the channel 44 and the lower edge 50 b is positioned near a second end 46 b and defines a second opening of the channel 44. The first edge 50 a and the second edge 50 b are rounded, although it will be appreciated that the edges 50 a, 50 b can have any suitable shape configured to prevent cutting and/or other damage to the flexible strand 22 c.

Also as discussed above, the flexible strand 22 c can be fixed and/or anchored by an interference fit between an outer surface 52 of the tissue anchor 40 c and an inner surface of a respective hole 74 a, 74 b formed in a bone, such as second bone 6. In some embodiments, the body 42 c may include a circumference substantially equal to the circumference of a respective hole 74 a, 74 b. In other embodiments, the body 42 c may include a circumference less than the circumference of a respective hole 74 a, 74 b. When the anchor 40 e is inserted into a selected hole 74 a, 74 b, the outer surface 52 of the anchor 40 c is in contact with the inner surface 72 of the respective hole 74 a, 74 b and compress a portion of the flexible strand 22 c therebetween.

FIG. 6 illustrates a tissue anchor 40 d having a protrusion 60 defining an eyelet 62, in accordance with some embodiments. The tissue anchor 40 d is similar to the tissue anchors 40 a-40 c discussed above and similar description is not repeated herein. The protrusion 60 extends from the second end 46 b of the body 42 d. In some embodiments, the flexible strand 22 d can be passed from a first end 46 a of the body 42 d to a second end 46 b along an outer surface 52 and through eyelet 62. The eyelet 62 is sized and configured to receive the flexible strand 22 d therethrough. The flexible strand 22 d is passed from a first side 64 a of the eyelet 62 to a second side 64 b and returned to the first side 46 a of the tissue anchor 40 d along the outer surface 52. The flexible strand 22 d is compressed between the outer surface 52 of the anchor 40 d and an inner surface of a selected hole 74 a, 74 b when the anchor 40 d is inserted therein. The second end 26 b of the flexible strand 22 d can be pulled to advance the flexible strand 22 d through the eyelet 62 to reduce the length of the intermediate portion 26 c of the flexible strand 22 d. It should be noted that tissue anchor 40 d can be utilized in the embodiments disclosed herein.

FIG. 7 illustrates a cross-section of the first bone 4 and a second bone 6 having an anchoring construct 10 a coupled thereto. The anchoring construct 10 a is similar to the anchoring construct 10 discussed above, and similar description is not repeated herein. The anchoring construct 10 a includes a bone plate 12 a coupled to a first bone 4 and a flexible construct 30 configured to maintain the first bone 4 and the second bone 6 at a selected spacing. In some embodiments, the flexible construct 30 includes a primary strand 32 defining at least one adjustable loop 34 extending from a first end 36 a to a second end 36 b. The adjustable loop 34 is configured to extend through a bone tunnel 70 formed in the first bone 4 and the second bone 6. The primary strand 32 can include any suitable material, such as a suture, ribbon, and/or other suitable material

In some embodiments, a first end 36 a of the adjustable loop 34 is coupled to the bone plate 12. The first end 36 a of adjustable loop 34 can be coupled directly to the bone plate 12 and/or an anchoring element (such as a knot capsule, button, and/or other anchoring element) coupled to the bone plate 12. In the illustrated embodiment, the first end 36 a of the adjustable loop 34 is coupled to a knot capsule 38 inserted through a capsule hole 24 c defined through the bone plate 12 a. A second end 36 b of the adjustable loop 34 is coupled to the second bone 6 by a second anchoring element, such as a button 82.

In some embodiments, the knot capsule 38 includes an adjustable knot and/or other fixation mechanism configured to maintain the adjustable loop 34 at a selected length. For example, in some embodiments, the knot capsule 38 includes a slip-knot, such as a prusik knot, configured to lock the adjustable loop 34 at a selected length to maintain a selected syndesmotic spacing between the first bone 4 and the second bone 6. In other embodiments, the capsule anchor 38 can include any suitable locking mechanism for locking the adjustable loop 34 at a selected length. International Patent Application PCT/US2016/066902, filed on Dec. 15, 2016, entitled “Knotless Syndesmosis System” discloses additional details regarding flexible constructs, and is incorporated by reference herein in its entirety.

The adjustable loop 34 can be adjusted to position the first bone 4 and the second bone 6 in a selected spacing. After positioning the first bone 4 and the second bone 6 using the flexible construct 30, a first flexible strand 22 a and the second flexible strand 22 b can further coupled to the first bone 4 and/or the second bone 6. The flexible strands 22 a, 22 b each extend from the bone plate 12. The first flexible strand 22 a is coupled to the second bone 6 by a first tissue anchor 40 a and the second flexible strand 22 b is coupled to the second bone 6 by a second tissue anchor 40 b. The length of the intermediate portion 26 c of the respective flexible strands 22 a, 22 b extending between the bone plate 12 a and the respective anchors 40 a, 40 b is adjusted prior to and/or simultaneous with implantation of the tissue anchors 40 c, 40 d to further couple the first bone 4 and the second bone 6. For example, as discussed above, the flexible strands 22 a, 22 b can be advanced through a channel 44 formed in respective tissue anchors 40 a, 40 b to decrease the length of the intermediate portion 26 c of the respective flexible strands 22 a, 22 b.

In some embodiments, the first flexible strand 22 a and/or the second flexible strand 22 b are formed integrally with the primary strand 32 defining the adjustable loop 34. For example, in some embodiments, the primary strand 32 (which defines the adjustable loop 34) includes a first end portion 32 a and a second end portion 32 b extending from the adjustable loop 32 in the same direction. In some embodiments, the first end portion 32 a extends from the knot capsule 38 and is coupled to the first tissue anchor 40 a and the second end portion 32 b extends from the knot capsule 38 and is coupled to the second tissue anchor 40 b. In this embodiment, the first flexible strand 22 a and the first end portion 32 a are the same and the second flexible strand 22 b and the second end portion 32 b are the same. The flexible strands 22 a, 22 b extend from and are formed integrally with the primary strand 32.

In other embodiments, the first flexible strand 22 a and/or the second flexible strand 22 b can be separate strands coupled to the adjustable loop 34, the knot capsule 38, and/or the bone plate 12. For example, in some embodiments, the first flexible strand 22 a and the second flexible strand 22 b are independent strands coupled directly to a portion of the bone plate 12 and extending from the bone plate 12 to respective anchors 40 a, 40 b.

In some embodiments, the end portions 32 a, 32 b of the primary strand 32 can be pulled to shorten the length of the adjustable loop 34 extending between the knot capsule 38 and the button 82 prior to and/or simultaneous with implantation of the tissue anchors 40 a, 40 b. For example, in some embodiments, the end portions 32 a, 32 b are used to adjust the adjustable loop 34 to a selected length to maintain the first bone 4 and the second bone 6 at a selected spacing. Subsequently, the end portions 32 a, 32 b are coupled to the second bone 6 using respective tissue anchors 40 a, 40 b. Coupling the end portions 32 a, 32 b to the second bone 6 provides additional fixation of the first bone 4 and the second bone 6 and/or fixation of soft tissue to the second bone 6.

In some embodiments, coupling the end portions 32 a, 32 b to the second bone 6 also provides further anchoring the adjustable loop 34 and prevents unwanted lengthening of the adjustable loop 34. For example, in some embodiments, the end portions 32 a, 32 b are pulled to shorten the adjustable loop 34 to a selected length to maintain the first bone 4 and the second bone 6 at a selected spacing. Each of the end portions 32 a, 32 b is coupled to the second bone 6 by respective tissue anchors 40 a, 40 b. The interference fit between the tissue anchors 40 a, 40 b and respective end portions 32 a, 32 b maintains the adjustable loop 34 at the selected length.

FIG. 8 illustrates an anchoring construct 10 b including a flexible construct 30 a and a flexible strand 22 e, in accordance with some embodiments. The anchoring construct 10 b is similar to the anchoring construct 10 a discussed above but omits the bone plate 12 a, and similar description is not repeated herein. The flexible construct 30 a includes a knot capsule 38 a coupled an adjustable loop 34. The knot capsule 38 a is inserted into a first end 70 a of the bone tunnel 70 formed through the first bone 4 and the second bone 6. The adjustable loop 34 extends from the knot capsule 38 a to a second end 34 b. The second end 34 b is coupled to the second bone 6 by a button 82 abutting an outer surface of the second bone 6. The flexible construct 30 a is similar to the flexible construct 30 discussed above, and similar description is not repeated herein.

In some embodiments, a flexible strand 22 e extends from the knot capsule 38 a. The flexible strand 22 e is coupled to the knot capsule 38 a at a first end 26 a. The first end 26 a can be coupled to any suitable portion of the knot capsule 38 a. For example, in some embodiments, the flexible strand 22 e is coupled to a knot formed in the knot capsule 38 a. In other embodiments, the first adjustable loop 34 is formed of a flexible strand having a first free end. The first free end extends from the knot capsule 38 a as the flexible strand 22 e. The flexible strand 22 e can be formed integrally with the adjustable loop 34 and/or can be a separate flexible strand. The second end 26 b of the flexible strand 22 e is coupled to a tissue anchor 40 a. The tissue anchor 40 a is configured couple the second end 26 b of the flexible strand 22 e to one of a first bone 4 or a second bone 6. The anchoring construct 10 b is configured to maintain the first bone 4 and the second bone 6 at a selected spacing and/or to couple soft tissue to the first bone 4 and/or the second bone 6, as discussed above.

FIG. 10 illustrates an anchoring construct 10 c including a tissue anchor 40 d having an internal peg 45, in accordance with some embodiments. The anchoring construct 10 c is similar to the anchoring construct 10 b discussed above, and similar description is not repeated herein. In the illustrated embodiment, the anchoring construct 10 c includes a tissue anchor 40 d having a first end 34 a of an adjustable loop 34 coupled thereto. The tissue anchor 40 d is sized and configured to be passed through a fastener hole 20 a formed in the bone plate 12. The tissue anchor 40 d is passed through the fastener hole 20 a such that the adjustable loop 34 extends through the fastener hole 20 a. The tissue anchor 40 d is coupled to a second bone 6.

In some embodiments, the tissue anchor 40 d includes an internal channel 44 and a peg 45 extending through the internal channel 44. The primary strand 32 of the adjustable loop 34 is passed around the peg 45 to couple the adjustable loop 34 to the tissue anchor 40 d. In some embodiments, the peg 45 enables the adjustable loop 34 to the tightened and/or loosened after installation of the tissue anchor 40 d in the second bone 6, as discussed in greater detail below. In some embodiments, the tissue anchor 40 d includes an internal locking mechanism (not shown) configured to prevent the adjustable loop 34 from loosening after being tightened.

In some embodiments, the adjustable loop 34 extends through a bone tunnel 70 formed in the first bone 4 and the second bone 6. A second end 34 b of the adjustable loop 34 is coupled to an anchor, such as a button 82, positioned against the first bone 4. Although embodiments are illustrated including a button 82, it will be appreciated that the anchor can include one or more of a button, a knot capsule, a bone plate, and/or any other suitable structure. The adjustable loop 34 defines a knot 80, such as a self-tightening knot, configured to tighten and/or loosen the adjustable loop 34. The adjustable loop 34 can be shortened to position the first bone 4 and the second bone 6 at a predetermined spacing. In some embodiments, the adjustable loop 34 is positioned within a knot capsule (not shown) including one or more features configured to tighten and/or maintain the knot 80 and/or the adjustable loop 34.

FIG. 9 illustrates a method of syndesmosis 100, in accordance with some embodiments. With reference to FIGS. 1-9, the method 100 is discussed. At optional step 102, a bone tunnel 70 is formed through a first bone 4 and a second bone 6. The bone tunnel 70 extends from a first side of the first bone 4 to a second side of a second bone 6. The bone tunnel 70 is sized and configured to receive an adjustable loop 34 therethrough.

At step 104, an anchoring element, such as a bone plate 12 or a knot capsule 38, is coupled to the first bone 4. In some embodiments, the bone plate 12 is coupled to the first bone 4 by inserting one or more fasteners through fastener holes 20 a, 20 b formed in the bone plate 12. The fasteners can be any suitable fasteners, such as a screw, a pin, and/or any other suitable fixation element. In other embodiments, a knot capsule 38 can be coupled directly to the first bone 4, for example, by inserting the knot capsule 38 at least partially into the bone tunnel 70. The bone plate 12 and/or the knot capsule 38 can include at least one flexible strand 22 a, 22 b extending therefrom.

At optional step 106, an adjustable loop 34 of a flexible construct 30 is inserted through the bone tunnel 70 and coupled to the first bone 4 and/or the second bone 6. The adjustable loop 34 can be inserted through the bone tunnel 70 using any suitable mechanism, such as, for example, a needle coupled to a pull strand inserted through the bone tunnel 70, although it will be appreciated that any suitable insertion mechanism can be used. The adjustable loop 34 can be coupled to the first bone 4 using any suitable anchor, such as the knot capsule 38, a button, and/or any other suitable anchor. In some embodiments, the adjustable loop 34 is coupled to the first bone 4 prior to, simultaneous with, and/or after coupling the bone plate 12 and/or knot capsule 38 to the first bone. In some embodiments, second end 36 b of the adjustable loop 34 is coupled to the second bone using a button 82. The adjustable loop 34 and/or the knot capsule 38 can be inserted through a capsule hole 20 c defined through the bone plate 12.

At optional step 108, the adjustable loop 34 is adjusted to maintain the first bone 4 and the second bone 6 at a selected spacing. For example, in some embodiments, one or more free ends extending from the adjustable loop 34 can be pulled to adjust the length of the adjustable loop 34. The adjustable loop 34 is shortened to position the first bone 4 and the second bone 6 at the selected spacing. In some embodiments, the adjustable loop 34 can be locked at a selected length using any suitable mechanism, such as, for example, a self-tightening knot positioned within a knot capsule 38.

At step 110, a length of an intermediate portion 26 c of each of flexible strands 22 a, 22 b is adjusted. The flexible strands 22 a, 22 b extend from the bone plate 12 and/or the knot capsule 38. In some embodiments, the flexible strands 22 a, 22 b extend from the adjustable loop 34. The intermediate length 26 c of a respective flexible strand 22 a, 22 b is adjusted by advancing the flexible strand 22 a, 22 b through a portion of the respective tissue anchor 40 a, 40 b. For example, in various embodiments, the flexible strands 22 a, 22 b can be advanced through a channel 44 and/or an eyelet 62 defined by the anchor 40 a, 40 b to shorten the intermediate length 26 c of the respective flexible strand 22 a, 22 b. In some embodiments, each of the flexible strands 22 a, 22 b define a loop 48 around a portion of a respective tissue anchor 40 a, 40 b. The second end 26 b of the flexible strand 22 a, 22 b is pulled to decrease the length of the intermediate portion 26 c.

At option step 112, one or more of the flexible strands 22 a, 22 b is coupled to a soft tissue section. The soft tissue section can include any suitable soft tissue, such as connective tissue, ligaments, muscle, etc. The soft tissue can be coupled to the flexible strands 22 a, 22 b by a respective tissue anchor 40 a, 40 b and/or by passing the flexible strands 22 a, 22 b through the soft tissue.

At step 114, one or more flexible strands 22 a, 22 b are coupled to the one of the first bone 4 and/or the second bone 6. The flexible strands 22 a, 22 b are coupled to a selected bone 4, 6 by a respective tissue anchor 40 a, 40 b coupled to a second end 26 b of the flexible strand 22 a, 22 b. In some embodiments, the length of an intermediate portion 26 c of one or more flexible strands 22 a, 22 b is fixed by an interference fit between an outer surface 52 of a respective anchor 40 a, 40 b and an inner surface 72 of a respective anchor hole 74 a, 74 b formed in the second bone 6. The flexible strand 22 a, 22 b is wedged between the anchor 40 a, 40 b and the inner surface of the respective anchor hole 74 a, 74 b.

Although the subject matter has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments, which may be made by those skilled in the art. 

1. A method, comprising: forming a bone tunnel through a first bone and a second bone; inserting a flexible construct through the bone tunnel, the flexible construct including a first anchoring element and a second anchoring element coupled by at least one flexible strand defining an adjustable loop, the at least one flexible strand including a first end extending from the first anchoring element in an opposite direction from the adjustable loop; adjusting a length of the adjustable loop to position the first bone and the second bone in a selected spacing; and coupling the first end of the at least one flexible strand to a tissue section using a third anchoring element.
 2. The method of claim 1, comprising adjusting a length of an intermediate portion of the at least one flexible strand.
 3. The method of claim 1, wherein third anchoring element comprises a tissue anchor.
 4. The method of claim 3, wherein the first end of the at least one flexible strand is coupled to the tissue section by an interference fit.
 5. The method of claim 3, wherein the tissue anchor comprises a body defining a channel, and wherein the at least one flexible strand extends at least partially into the channel.
 6. The method of claim 5, wherein the at least one flexible strand defines a loop about a portion of the body of the tissue anchor.
 7. The method of claim 1, wherein the first anchoring element is selected from the group consisting of a knot capsule, a bone plate, a tissue anchor, and a button.
 8. The method of claim 1, wherein the second anchoring element is selected from the group consisting of a knot capsule, a bone plate, a tissue anchor, and a button.
 9. The method of claim 1, coupling a second free end of the at least one flexible strand to the tissue section using a fourth anchoring element, wherein the second end extends from the first anchoring element in an opposite direction from the adjustable loop.
 10. The method of claim 1, comprising coupling a bone plate to the first bone, wherein the flexible construct passes therethrough the bone tunnel through a hole defined by the bone plate. 11.-20. (canceled) 